Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis

Fondazione Italiana Sclerosi Multipla

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Voluntary-based upper limb motor rehabilitation; Behavioral: Passive upper limb mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT03608527

FISM 2011R8

Details and patient eligibility

About

Motor learning can induce significant changes in the human brain through neural plasticity processes, which play a crucial role in the brain functional reorganization in response to external stimuli and/or to pathological conditions. For example, people with multiple sclerosis present motor deficits often associated with cerebral activity alteration. However, whether these brain activation changes contribute to or protect against motor performance deficits still needs to be determined.

Moreover, rehabilitation protocols could be designed to obtain efficient brain adaptation to preserve patients' outcome, but consistent data on the real efficacy of rehabilitative procedures are lacking, in particular concerning the rehabilitation effect on brain networks.

Therefore, this project focuses on the degree to which imaging measures of functional brain activity can give new hints on the effects of motor rehabilitative protocols in multiple sclerosis patients' performance. Particularly, the investigator's aim is to investigate the effects of upper limb rehabilitation, focused on hand motor function, and the correlation between motor performance and functional magnetic resonance data.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multiple sclerosis diagnosis according to McDonald criteria
• right handedness as assessed by the Edinburgh Handedness Inventory
• absence of relapses in the last three months
• mild or moderate sensorimotor impairment in one or both upper limbs as evaluated by means of the Medical Research Council scale (grade 3-4)

Exclusion criteria

• steroid-use or a worsening of the Expanded Disability Status Scale (EDSS) score in the last three months
• psychiatric disorders
• severe cognitive impairment
• magnetic resonance imaging contraindications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Active motor treatment (AMT) group

Experimental group

Description:

15 people with multiple sclerosis performing a 8 week rehabilitative treatment based on task-oriented voluntary exercises (3 sessions/week).

Treatment:

Behavioral: Voluntary-based upper limb motor rehabilitation

Passive motor treatment (PMT) group

Active Comparator group

Description:

15 people with multiple sclerosis performing a 8 week passive mobilization delivered by a physical therapist (3 sessions/week).

Treatment:

Behavioral: Passive upper limb mobilization